Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial (PERFUSERCT)

Young-Hak Kim, MD, PhD

Status: Enrolling

Conditions: Coronary Disease

Treatments: Device: Fractional flow reserve guided treatment; Device: computed tomography perfusion guided treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02208388

AMCCV2014-06

Details and patient eligibility

About

The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization

Enrollment: 1,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 20 and more
• Diagnosed angina or angina equivalent symptom or positive exercise treadmill test
• Patients with intermediate- or high-risk probability of CAD defined by Diamond and Forester
• 70 % stenosis or more in coronary CTA
• Willing to provide informed, written consent

Exclusion criteria

• Requirement for surgical procedure
• Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
• Recent STEMI (<5 days)
• Non STEMI, if the cardiac troponin is not stable or starting to decline
• Left ventricular ejection fraction <30%
• Life expectancy <2 years
• Impaired renal function with an effective glomerular filtration rate less than 30mL/min/1.73 ㎡ or creatinine more than 2.0 mg/dL
• Undergoing evaluation for organ transplantation
• Participation or planned participation in another cardiovascular clinical trial
• Pregnancy
• Inability to take dual antiplatelet therapy for six months
• Previous CABG
• Left main disease requiring revascularization
• Any target lesion with in-stent restenosis
• NYHA class 3 or 4a
• Severe and persistent angina with severe limitation in everyday living activities (Canadian Cardiovascular Society grading Class IV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,000 participants in 2 patient groups

Computed tomography perfusion

Experimental group

Description:

Patients with Computed tomography perfusion

Treatment:

Device: computed tomography perfusion guided treatment

Fractional flow reserve

Active Comparator group

Description:

Patients with Fractional flow reserve

Treatment:

Device: Fractional flow reserve guided treatment